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510(k) Data Aggregation
K Number
K082822Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
2008-10-22
(27 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO ZHUANGYUAN PLASTIC **PRODUCTS COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contammation between patient and examiner.
Device Description
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed
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K Number
K050154Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Manufacturer
Date Cleared
2005-02-07
(14 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO ZHUANGYUAN PLASTIC **& RUBBER CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
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K Number
K050155Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Manufacturer
Date Cleared
2005-02-07
(14 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**ZIBO ZHUANGYUAN PLASTIC **& RUBBER CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004
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Ask a specific question about this device
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